510(k) · Cleared
ClearedCardiomedics Ecp System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiomedics, Inc. · DRN Device, Counter-Pulsating, External
Cleared on Feb 28, 2001 after a 30-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Feb 28, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- DRN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK010261 Cardiomedics Ecp SystemCardiomedics, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK022107 Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK023427 Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK082134 Circulator BootCirculator Boot Corp. · 2009
- Descendant · 3 generations on · 0 of its ownK050172 Cardiassist Counter Pulsation System Series 4000/5000Cardiomedics, Inc. · 2005 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K022107Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2002 · cites it directly3descendants
- K023427Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2003 · 2 generations on1descendant
- K082134Circulator BootCirculator Boot Corp. · 2009 · 2 generations on0descendants
- K050172Cardiassist Counter Pulsation System Series 4000/5000Cardiomedics, Inc. · 2005 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010261 | Cardiomedics Ecp System | Cardiomedics, Inc. | 2001 | — |
| +1 | K022107 | Cardiassist Counterpulsation System, Model Mark 3000 | Cardiomedics, Inc. | 2002 | — |
| +2 | K023427 | Cardiassist Counterpulsation System, Model Mark 3000 | Cardiomedics, Inc. | 2003 | — |
| +2 | K082134 | Circulator Boot | Circulator Boot Corp. | 2009 | — |
| +3 | K050172 | Cardiassist Counter Pulsation System Series 4000/5000 | Cardiomedics, Inc. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRN device
- #1 K250756 Pression Wave PRO External Counter-Pulsation…score 10.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022107 | Cardiassist Counterpulsation System, Model Mark 3000 | 2002 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022107 (Cardiomedics, Inc., 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DRN devicesDRN Device, Counter-Pulsating, External: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRN
Too few DRN 510(k)s in any year since 2007 to give a median.
Recalls per year · DRN
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRN
1in 2024
MAUDE reports naming product code DRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K010261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010261: Cardiomedics Ecp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010261
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026